AVI BioPharma Manufactures West Nile Virus Antisense Drug
New GMP Manufacturing Facility Produces Drug for Clinical Trials
PORTLAND, Ore. - July 7, 2003 - AVI BioPharma, Inc. (Nasdaq: AVII, AVIIW, AVIIZ), today announced that it has completed manufacturing of several lots of its West Nile virus NEUGENE® antisense drug, AVI-4020, at its new manufacturing facility in Corvallis, Ore. AVI has filed an Investigational New Drug application with the U.S. Food and Drug Administration and intends to initiate a clinical trial with AVI-4020 in West Nile virus patients this summer.
"Our ability to manufacture NEUGENE drugs in our own facilities provides us with substantial control over the timing and cost of producing experimental drugs for use in clinical trials," said Dwight Weller, Ph.D., senior vice president of chemistry and manufacturing at AVI. "Building and qualifying a manufacturing facility represents the culmination of our intensive efforts to assume hands-on responsibility for manufacturing and product development of our third-generation antisense drugs."
Denis Burger, Ph.D., AVI's chief executive officer, added that "This advance represents a substantial step in AVI's progress toward our goal of bringing NeuGene antisense drugs into the market place. The efforts of our employees in making this happen should be applauded."
About AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: third-generation NEUGENE antisense drugs and cancer immunotherapy. AVI's lead NEUGENE antisense compound is designed to target cardiovascular restenosis, cancer, polycystic kidney disease and other cell proliferation disorders. In addition to targeting specific genes in the body, AVI's antiviral program uses NEUGENE antisense compounds to target single-stranded RNA viruses, including West Nile virus, SARS coronavirus, calicivirus, and Hepatitis C. AVI's second technology, AVICINE®, is a therapeutic cancer vaccine with late-stage trials planned for the treatment of pancreatic and colorectal cancer. More information about AVI is available on the company's Web site at http://www.avibio.com/.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of preclinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the Company's Securities and Exchange Commission filings.